ContraFect Submits Complete Response to IND Clinical Hold for CF-301
YONKERS, NY -- (Marketwired) -- 12/02/14 -- ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced today that it has submitted a complete response to the U.S. Food and Drug Administration (FDA). The complete response addresses all of the issues identified in the Investigational New Drug Application (IND) clinical hold letter issued by FDA.
The IND is for ContraFect's most advanced program, CF-301, and is for the combination of CF-301 and antibiotics for the treatment of Staphylococcus bacteremia, including infective endocarditis, caused by methicillin-sensitive (MSSA) and methicillin-resistant S. aureus (MRSA).
Julia P. Gregory, ContraFect's chief executive officer commented, "This submission achieves a very important milestone for ContraFect this year. While FDA will make the ultimate decision regarding whether our clinical trial may proceed, we have addressed all of their questions. CF-301 has the potential to make a major impact on the important unmet needs of treating Staph blood stream infections and addressing the global crisis of drug-resistance."
CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. Staph infections occur in both hospital and community settings, and in the U.S. there are approximately 120,000 cases annually of Staph bacteremia (a blood borne infection), which causes approximately 30,000 deaths. Of further concern, drug-resistant strains of Staph are now evolving additional resistance against standard-of-care antibiotics, which may ultimately result in increased number of cases and mortality from Staph bacteremia. CF-301 is a bacteriophage lysin that has the potential to be a first-in-class treatment for Staph bacteremia. CF-301 has specific and rapid bactericidal activity against Staph. Combinations of CF-301 with vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 targets a conserved region of the cell wall that is vital to bacteria, thus making resistance less likely to develop. When used in combination with standard of care antibiotics, the result is a novel combination therapy that has the potential to combat the high unmet clinical need of S. aureus infections.
ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.
This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Source: ContraFect Corporation
Released December 2, 2014